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The Expanded Spectrum Photo Therapy Device (ESPT-3X) is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for:

• the temporary relief of minor muscle and joint pain and stiffness, .
• minor arthritis pain, .
• muscle spasm, 0
• the temporary increase in local blood circulation and/or .
• promoting relaxation of muscle. .

The ESPT-3X is for prescription use only.

The ESPT-3X console is a non-invasive, portable, therapeutic medical laser designed to deliver high level (Class IV) energy/power for the purpose of reducing musculoskeletal pain. A "hand piece" accessory evenly delivers a Class IV laser to the target tissue. This channel is equipped with a red aiming beam (1 mW) that provides visible illumination of the area being treated. The console is equipped with a separate and independent timer that is manually set by the operator.

The provided 510(k) summary for the K083560 device (Expanded Spectrum Photo Therapy Device (ESPT-3X)) does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a clinical or comparative effectiveness study.

This type of 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a standalone clinical trial with performance metrics against acceptance criteria.

The document indicates:

• Intended Use: The device is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain/stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and promoting muscle relaxation.
• Technical Characteristics and Substantial Equivalence: The ESPT-3X provides Class IV therapy and has the "same technological characteristics (e.g., wavelength, power, and frequency) as other commercially available Class IV devices." It was "tested extensively to ensure conformance to applicable standards and FDA regulations."

Since the provided text does not describe a study with specific acceptance criteria and performance results, I cannot fill in the requested table and details. The 510(k) process often relies on demonstrating substantial equivalence to already cleared devices, meaning extensive new clinical performance data might not be required if the technological characteristics and intended use are similar, and safety is established through conformance to standards.

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